Forest Labs to ship Daliresp tablets

June 10th, 2011

NEW YORK – Forest Laboratories Inc. plans to roll out Daliresp tablets, a medication for chronic obstructive pulmonary disease (COPD), to U.S. pharmacies by mid-June.

The company said late Thursday that Daliresp (roflumilast) was recently approved by the Food and Drug Administration as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

According to Forest Labs, the once-daily Daliresp (500 mcg) oral tablet is the first and only selective phosphodiesterase-4 (PDE4) inhibitor approved by the FDA.

In August 2009, Forest Labs and Nycomed entered into a collaboration and distribution agreement in which Forest acquired an exclusive license for Daliresp in the United States. Roflumilast is marketed in the European Union, Canada and other territories as Daxas.

An irreversible lung disease, COPD is the third-leading cause of death in the United States, Forest Labs reported. About 12 million Americans are currently diagnosed with COPD, and another 12 million are likely to have the disease and not know. Approximately half of COPD patients treated by a physician with controller medications have severe COPD, and of the patients diagnosed with severe COPD, almost three-quarters, or 2.8 million, have chronic bronchitis.

Symptoms of COPD include breathlessness, chronic cough and excessive production of phlegm, Forest Labs said. A significant worsening of symptoms, called an exacerbation, can last several weeks and often requires substantial medical intervention, including hospitalization. Exacerbations can result in worsening health status, lung function decline and increased risk of death.